BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2791643 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05641
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    Z-0110-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT EXPERIENCED A SHOCK FROM AN ELECTRIC FENCE AND HAS NOT "FELT WELL" SINCE; THE PATIENT HAS BEEN TIRED AND EXPERIENCING FLUID BUILD-UP. THE PATIENT SAW A PHYSICIAN, BUT DID NOT DISCUSS THE SHOCK FROM THE ELECTRIC FENCE AND THE PHYSICIAN PRESCRIBED A "FLUID MEDICATION." THE PATIENT REPORTS STILL NOT FEELING WELL AND ONE WEEK HAS ELAPSED. THE PATIENT WAS ENCOURAGED TO DISCUSS THE SHOCK WITH THE PHYSICIAN AND THE DEVICE REMAINS IN USE. REQUESTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN ON FILE REVEALED THAT THE CLINIC DOES NOT HAVE THE PATIENT NAME ON RECORD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 1056T COMPETITOR IMPLANTABLE PACING LEAD| 1580 COMPETITOR IMPLANTABLE TACHY LEAD| 1488T COMPETITOR IMPLANTABLE PACING LEAD